Method for inducing hypothermia in a patient

ABSTRACT

A therapeutic collar comprising an elongate body made from a flexible material for extending around at least a portion of the neck of a patient. The body has a length approximating the circumference of the neck, two thermoelectric devices for overlying two carotid arteries in the neck and two thermoelectric devices for overlying of two vertebral arteries in the neck when the elongate body is secured around the neck of the patient. At least one cooling tube is carried by the elongate body and extends in the vicinity of each of the thermoelectric devices for removing heat from the thermoelectric devices.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. nonprovisional application Ser.No. 14/633,824 filed Feb. 27, 2015, which is a continuation in part ofInternational Application Number PCT/IB2013/059262 filed Oct. 10, 2013,which claims priority to Italian Patent Application No. MO2012A000246filed Oct. 10, 2012, the entire content of each of which is incorporatedherein by this reference.

FIELD OF THE INVENTION

The invention relates to a therapeutic collar, more particularly to atherapeutic collar for cooling a patient's neck.

BACKGROUND OF THE INVENTION

Collars have been provided for use with severe trauma patients. Some ofthese collars have a structure that immobilizes or restricts themovements of the head relative to the spine, such that noexternally-induced or patient-induced hazardous movements might endangerthe overall patient's safety. In practice, such collars can inhibit orlimit head movements, for example prevent reclination or upward rotationof the head beyond a given angle relative to the spine, and limit crushor sprain injuries to vertebrae and cervical nerves due to externalimpact trauma or a cervical disease. Typically, these collars are usedon patients involved in road accidents to prevent movements duringtransportation to hospital or during later convalescence from furtherworsening any injury suffered due to the accident. Some of such collarsare formed from two semi-annular portions which are mutually articulatedto open apart for application to the neck, and to close for maintainingthe correct position of the neck and head relative to the spine.

Collars are also known that have a semi-rigid structure, typically madeof synthetic foam material, to act as transition supports fromrigid-collar therapy to the end of the therapy. With time, these collarshave been also used in other forms of therapy, such as those for thermaltreatment of the circulatory system of the neck that supplies blood tothe brain. In practice, apertures can be formed in such collars, namelyin the throat section thereof, for introduction and stable but removablepositioning of corresponding cooling elements, which have beenpreviously placed and maintained in a refrigerating unit. Such coolingelements can release cold during use, and can be positioned at thecarotid artery, the artery that supplies blood to the brain and extendsthrough the front area of the neck, when such collars are closed aroundthe neck.

A cooling collar of the foregoing type is disclosed in InternationalPublication Number WO2012/058427, which teaches an “Immobilizationcollar with cooling elements and method of using the same”. The collaris actually a cervical immobilizer that has an annular support structurehaving an axial length and at least two support structures. The collarhas a front opening that may be closed by a door having a pressuremember on the inner neck-facing surface. This pressure member can pressa cooling element against the front portion of the patient's neck, whichcooling element is inserted between the collar and the neck through thefront opening.

The foregoing collars suffer from a number of drawbacks. A firstdrawback is that such collars that are used for first rescue of patientshave a rigid structure, which is specially designed to inhibit anymovement of the neck and spine in the proximity of the cervicalvertebrae when this part of the body suffers from a traumatic injury ora bone disease. A second drawback is that the cooling elements that areused therein have a temporary effect that progressively decreases withtime, especially because they are taken out of the refrigerator andplaced in contact with the warm epidermis of the neck. Therefore, thecooling elements must be replaced after a certain time interval tomaintain a desired low temperature value required by the therapeuticneeds of patients. The replacement of these cooling elements isconsiderably uncomfortable for patients that already suffer fromnormally painful diseases as such replacement often requiresmanipulation of collars by the operator, with the risk of causingmovements that are hazardous for the vertebrae of the patient and mightaffect the patient's physical recovery. Furthermore, in case of diseasesthat are not caused by head trauma but instead by cerebral anoxia orhypoxia, for example due to a cardiac arrest, the use of such collarscan be inappropriate as the collars can immobilize the patient andhinder treatment or makes therapy useless.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present invention in any way.

FIG. 1 is a perspective schematic view of one embodiment of atherapeutic collar of the present invention in a first or closedconfiguration.

FIG. 2 is a front schematic view of the collar of FIG. 1 in a second oropen configuration that provides a view of the interior of the collar.

FIG. 3 is a broken cross-sectional view of a portion of the collar ofFIG. 1, as taken along the line 3-3 of FIG. 2.

FIG. 4 is a highly schematic view of the head and neck of a patientwearing one embodiment of the therapeutic collar of the presentinvention.

FIG. 5 is a highly schematic top view of a network of intracranial bloodvessels, known as Circle of Willis, which supplies blood to the brain orencephalic region of a human being.

FIG. 6 is a highly schematic perspective and phantom view of a secondembodiment of the collar of the present invention.

FIG. 7 is a small-scale schematic view of one embodiment of a connectionarrangement between the cooling units of the collar of FIG. 6.

FIG. 8 is a schematic view of another embodiment of a connectionarrangement between the cooling units of the collar of FIG. 6.

FIG. 9 is a schematic cross-sectional view of the therapeutic collar ofFIG. 6, as taken along the line 9-9 of FIG. 8.

FIG. 10 is a front schematic view, similar to FIG. 2, of anotherembodiment of a therapeutic collar of the present invention, in a secondor open configuration that provides a view of the interior of thecollar.

FIG. 11 is a highly schematic view, similar to FIG. 4, of the head andneck of a patient wearing the therapeutic collar of FIG. 10.

DETAILED DESCRIPTION OF THE INVENTION

In one embodiment of the invention, a therapeutic collar of disposabletype is provided that allows constant thermal treatment of the neck zonewith the arteries that supply one or more of the brain 10, cerebellum 11and other intracranial structures for as long as desired. In oneembodiment, the collar can decrease its temperature to a desired valueto induce hypothermia and preserve for a given time the cerebralfunctions of a patient after cerebral anoxia or hypoxia or other seriousinjuries of the cranial or encephalic region. In one embodiment, thetemperature of the collar is decreased to a temperature ranging from32.0 degrees C. (89.6 degrees F.) to 36.0 degrees C. (96.8 degrees F.),and in one embodiment the collar is decreased to a temperature ofapproximately 34.0 degrees C. (93.2 degrees F.). The collar can sooperate both during first rescue operations and during the followingtherapies at the hospital. The therapeutic collar can be interfaced witha control unit, for example for controlling and adjusting the thermalconditions to be provided in contact with the patient's neck. Thepatient can be any suitable mammalian body, and in one embodiment is ahuman.

Referring now to FIGS. 1 to 5 and 10 to 11, numeral 1 generallydesignates a therapeutic collar or device, which in one embodiment is ofa disposable type. Collar 1 can include an elongate body 2 having alongitudinal axis “A” and can have a front cut to define a dividingplane 2-2 that divides it into two sections 3 and 4, which can be ends.The first and second sections 3, 4 may be elastically opened apart toallow the collar 1 to be worn around the neck 40 of a patient “P” or tobe removed. The neck 40 of the patient has a circumference, and the body2 can have a length approximating the circumference of the neck of thepatient. In one embodiment, the length of the body 2 ranges from 30 to45 centimeters, in one embodiment the length of the body ranges from 35to 40 centimeters and in one embodiment the length of the body isapproximately 38 centimeters. The collar can be worn around at least aportion of the neck of the patient, and in one embodiment extends aroundthe entire circumference of the neck of the patient. When positioned ormounted on the neck of the patient, the body 2 is arcuate or annular inshape. Body 2 can include an inner surface 2A adapted for engaging theneck 40 of the patient and an opposite outer surface 2B.

As mentioned above, the collar 1 can be made of a disposable andflexible material, such as any suitable cellular urethane for examplePoron®. In one embodiment, the flexible material forms the inner portion5A and the outer portion 5B of elongate body 2. The two ends 3 and 4 canbe maintained in the closed state during use, using any suitable closuredevices that are known to a person skilled in the art such as tearstrips 6.

Cooling means or devices, generally referenced 7, are arranged in thebody 2 such that, when the collar 1 is closed around the neck 40 and inan annular configuration, they are located at any or all of the carotid8 and vertebral 9 arteries that extend along the neck 40 and supplyblood to the cranial-encephalic region, that is the brain 10 and thecerebellum 11 and all other anatomical structures in the territories orareas of the carotid and vertebral arteries 8, 9 (see FIGS. 2, 4, 10 and11). In one embodiment, the cooling means indirectly affects theanterior cerebral arteries 15 a, middle cerebral arteries 15 b,posterior cerebral arteries 15 c and basilar artery 15 d (see FIG. 5),which are intracranial vessels, by acting on the carotid 8 and vertebral9 arteries. The cooling means 7, which can also be referred to asrefrigerating means, can be secured to the elongated body 2 by anysuitable means. In one embodiment, the cooling means 7 are included inthe flexible material of the body 2 at the time of polymerization or bythe juxtaposition of an adhesive layer (not shown) between the coolingmeans external surface and the flexible material, for example where acavity of the exact or approximate size and shape of the cooling meansor element 7 has been created in the flexible material. For example withrespect to FIGS. 10 and 11, a first cooling assembly 7 can be placeddirectly over the carotid artery and the vertebral artery on one side ofthe neck 40 and a second cooling assembly 7 can be placed directly overthe carotid artery and the vertebral artery on the other side of theneck 40. As discussed below, each cooling assembly 7 can beindependently controlled.

In one embodiment, a first plurality of at least two cooling means orassemblies 7 a and a second plurality of at least two cooling means orassemblies 7 b are carried by the elongate body. In one embodiment, thefirst and second plurality of cooling assemblies or devices 7 are spacedapart along the length of the elongate body so that the first pluralityof at least two cooling devices or assemblies 7 a overlie respectivelythe first plurality of two carotid arteries 8 and the second pluralityof two cooling devices or assemblies 7 b overlie respectively the secondplurality of two vertebral arteries 9 when the elongate body is securedaround the neck of the patient. In one embodiment, one cooling device orassembly 7 overlies each carotid artery 8 and one cooling device orassembly overlies each vertebral artery 9. As such, one cooling deviceor assembly 7 a can overlie each of the two carotid arteries 8 extendingthrough the neck 40 of the patient, and one cooling device or assembly 7b can overlie each of the two vertebral arteries 9 extending through theneck of the patient. The therapeutic collar or device 1 of the inventioncan include additional cooling devices or assemblies 7. For example,more than one cooling device or assembly can be provided for each of thecarotid and vertebral arteries in the neck of the patient. For example,two or more cooling devices or assemblies 7 can overlie each or any ofthe carotid and vertebral arteries extending through the neck of thepatient.

As shown in FIG. 2, the cooling means 7 may comprise, according to oneembodiment, a plurality of thermoelectric devices or Peltier cells 12,which are placed in correspondence of or registration with the pluralityof carotid and vertebral arteries to be affected by the collar. In oneembodiment, the cooling means 7 are placed in spaced-apart positionalong the length of body 2 so as to accomplish such correspondence orregistration. In one embodiment, each of the cooling means or devices 7includes at least one Peltier cell or thermoelectric device 12, and inone embodiment each of the cooling means or devices 7 includes onePeltier cell or thermoelectric device 12.

In one embodiment, each of the cooling means or devices 7 may comprise aplurality of cooling tubes 13, and in one embodiment each of the coolingmeans or devices 7 includes at least one serpentine or other shaped tube13. Such tubes 13 can each be adapted or configured to carry atemperature-controlled liquid flows, which liquid can be supplied by apump unit 14 or any other suitable means and cooled to a predeterminedtemperature when provided to the collar 1, for example when the collar 1is mounted around the neck 40 of a patient. It is appreciated that oneor some of the cooling means 7, or all of the cooling means 7, may be acombination of thermoelectric devices 12 and at least one cooling tube13. For example, in FIG. 2 each of the two cooling means 7 on the rightof the elongate body 2 is a thermoelectric device 12 in combination withat least one cooling tube, for example at least one cooling tube 13 in aserpentine configuration. The at least one cooling tube 13 in anycooling means 7 may be in any other suitable configuration or shape,that is other than in a serpentine configuration.

The skilled person will understand that other solutions may be envisagedto make the cooling means 7. Such cooling means 7 can be positioned onthe inner surface 2A of the collar body 2 so as to overlie one, any orall of the carotid arteries 8 and the vertebral arteries 9 (see FIG. 4and FIG. 10 in particular) and thus provide a controlled hypothermiastate in the blood that flows there through. The cooling of any or allof such arteries can serve to induce hypothermia in the circulatorysystem that supplies the brain of the patient, for example the entirebrain or encephalic region of the patient.

In one embodiment of the collar 1 in which the cooling means 7 includesPeltier cells or thermoelectric device 12, for example as illustrated inFIGS. 1 and 3, apertures 16 can be provided for radiating out the heatgenerated by the heat transfer surfaces of the thermoelectric devices 12facing opposite to the neck 40 when the collar 1 is mounted on thepatient's neck.

Thermoelectric devices 12 are known to create two heat transfersurfaces, namely a cold surface 12A, in this case facing the neck 40 ofthe patient “P”, and an opposite and parallel heat-generating surface12B. In one embodiment of the invention, the heat generated at surface12 can be discharged through the apertures 16 provided in body 2 of thecollar 1.

In one embodiment, the elongate body 2 includes an inner portion 5A forengaging the neck 40 of the patient and an outer portion 5B opposite theinner portion. The portions 5A and 5B, each of which can be formed fromthe flexible material discussed above, can be tightly joined together toform the scaffold of collar 2. In one embodiment, the inner portion 5Aand the outer portion 5B can be joined together at the time ofpolymerization or by the juxtaposition of an adhesive layer (not shown)between them (see FIG. 9). The inner portion 5A can include innersurface 2A, and the outer portion 5B can include outer surface 2B. Inone embodiment, the inner portion 5A is thermo-conductive, and is thus athermo-conductive layer. In one embodiment, the inner portion 5A can bemade from a material having a thermal conductivity ranging from 0.2 to10.0 W/mK, in one embodiment the inner portion 5A or thermo-conductivelayer can be made from a material having a thermal conductivity rangingfrom 0.2 to 0.5 W/mK and in one embodiment the inner portion 5A orthermo-conductive layer can be made from a material having a thermalconductivity ranging from one to two W/mK. The inner portion 5A can bemade from any suitable material, such as a soft biocompatible polymer,an adhesive gel or a gel. In one embodiment, the outer portion 5B isthermo-insulating layer, and is thus a thermo-insulating layer. In oneembodiment, the outer portion 5B can be made from a material having athermal conductivity ranging from 0.01 to 0.19 W/mK and in oneembodiment the outer portion 5B can be made from a material having athermal conductivity ranging from 0.02 to 0.09 W/mK. The outer portion5B can be made from any suitable material, such as soft biocompatiblepolymer, a foam or a polyurethane. The thermo-conductive inner portion5A facilitates hypothermic exchange with the neck 40. Thethermo-insulating outer portion 5B can inhibit the outer surface 2B ofthe collar 1 from becoming hot and possible dangerous to the user orothers and can inhibit heat from the hot surface of the cooling means 7from traveling through the elongate body 2 of the cold surface of thecooling means 7.

The cold surface of the cooling means 7 contacts or engages the innerportion 5A of elongate body 2 while the hot surface of the cooling meansis in contact with or engages the outer portion 5B of the elongate body.Apertures 16 can be provided in the outer portion 5B to facilitate theremoval of heat from the hot surface of the cooling means, devices orassemblies 7 (see FIG. 3). In one embodiment, where the cooling means 7are formed by the coupling of a plurality of Peltier cells 12 with arespective plurality of cooling tubes 13, for example as discussedbelow, the cold surface of the Peltier cell 12 is in contact with theinner portion 5A of the elongate body 2, while the coupling of the hotsurface of the Peltier cell 12 and the cooling tubes 13 are included inthe outer portion 5B of the elongate body 2 (see FIG. 9). Heat-escapeapertures 16 can be provided for each of the cooling means assemblies 7having a Peltier cell 12 and at least one cooling tube 13 engaging thehot surface of the Peltier cell 12. In each case, the heat-removalfeatures or structure in the outer portion 5B enhances the removal ofheat from the hot surface of the Peltier device 12 so as to enhance therefrigerating efficiency of the cooling means 7.

Irrespective of whether the cooling means are in the form of Peltiercells 12 or serpentines 13, a combination of the foregoing or any othersuitable arrangement, is the system of the invention can be providedwith one or more temperature sensors 18 that can be connected to acontrol unit 19. The temperatures sensors 18 can be of any suitabletype, for example a thermocouple or other electrical sensor. The controlunit 19 can receive the electrical signals generated by the one or moretemperature sensors and, in response thereto, independently change andmaintain the temperatures of the cooling means 7 as needed or desired,for example to inhibit damage to the neck 40 during operation of thecollar 1 (see FIGS. 2 and 10). For example, the temperature of the neck40 overlying at least one of the carotid arteries and the vertebralarteries can optionally be measured and the at least one artery cooledin response to the measured temperature. The temperature of the neck 40overlying each of the carotid arteries can optionally be measured andthe cooling of each of the carotid arteries adjusted in response to therespective measured temperature of the carotid arteries. The temperatureof the neck overlying each of the vertebral arteries can optionally bemeasured and the cooling of each of the vertebral arteries adjusted inresponse to the respective measured temperature of the vertebralarteries. Such damage could have included damage to the skin of theneck, for example to the skin underlying the cooling means 7. In oneembodiment, a temperature sensor is carried by the elongate body 2 inthe vicinity of each of the cooling means 7. In one embodiment, asillustrated in FIG. 2 and FIG. 10, a temperature sensor 18 is providedin the elongate body 2 adjacent to or within the confines of eachcooling means 7. In one embodiment, temperature sensors 18 are providedin other areas of the patient's body, for example in, adjacent or nearcertain organs of the patient, and electrically coupled to the controlunit 19 for monitoring the temperature of such one or more areas andproviding feedback signals to the control unit 19 for use by the controlunit to adjust or maintain the energy provided by the control unit tothermoelectric devices 12 on collar 1. Such one or more othertemperature sensors 18 can be in addition to or in lieu of the one ormore temperature sensors 18 on collar 1, and can be located in or nearthe patient's brain, esophagus or bladder or any combination of theforegoing. In one embodiment, a probe having a temperature sensor at ornear the distal end thereof can be inserted into the brain. Invasivebrain temperature measurement, for example by the insertion of a thermalprobe into the brain tissue, can be direct and reliable technique tomeasure brain temperature. Esophagus and bladder can be suitable sitesfor the measurement of a proxy of the core temperature of the brain. Thetemperature of the esophagus and bladder are sometimes considered to bein equilibrium with the temperature of the brain. The temperature of theesophagus and bladder can be measured by any suitable means, for exampleby use of probes or other devices inserted into or nearby such organs.The combination of more techniques and sites for measuring bodytemperature, for example measuring the temperature of the brain, theesophagus, the bladder or any combination of the foregoing, can increasethe accuracy of creating a desired hypothermia or temperature in thebrain.

In one embodiment of the operation and use of the collar of the presentinvention, the collar is wrapped around all or at least a portion of theneck 40 of the patient. In one method of use, sections 3, 4 of thecollar are placed at the rear of the neck and thus serve as theposterior portion of the collar, while the middle portion of the collaris placed at the front of the patient's neck and thus serves as theanterior portion of the collar. It is appreciated that sections 3, 4, orthe opening portion of the collar 1, can be placed at the front of thepatient's neck or elsewhere around the neck with the cooling means ordevices 7 positioned on the elongate body 2 for registration with theneck arteries in the manner discussed herein. Electrical energy can thenbe supplied to one or more of the thermoelectric devices 12 of thecollar that overlie one or more of the arteries carrying blood to thehead of the patient so as to cool the blood passing through the arteriesto a suitable temperature for inducing hypothermia in the circulatorysystem that supplies the brain. In one embodiment, the blood passingthrough such one or more arteries is cooled to a temperature rangingfrom 89.6 to 96.8 degrees Fahrenheit. In one embodiment, electricalenergy is supplied to such one or more thermoelectric or Peltier devicesso as to cool the skin overlying such one or more arteries to atemperature not less than 39.2 degrees Fahrenheit, for example in oneembodiment to a temperature ranging from 41 to 55 degrees Fahrenheit. Itis appreciated that the foregoing temperature ranges can be relevant tocollars having cooling means or devices 7 that do not includethermoelectric or Peltier devices 12.

FIGS. 6 to 8 show a further possible embodiment of the collar of theinvention. Collar 31 is similar to collar 1 and like reference numeralshave been used to describe like components of collars 1 and 31. Forexample, collar 31 can include an inner portion 5A and an outer portion5B, each of which can be made from any suitable material such as theflexible material discussed above.

In this embodiment, the cooling means or assemblies 7 can comprise acombination of thermoelectric devices 12, such as Peltier cells 12, andat least one cooling tube 13, such as in a serpentine or other suitableconfiguration, in close contact with each other. An optional layer ofconductive gel 30, for example a gel containing metal salts, can beprovided or interposed between each thermoelectric device 12 and relatedat least one cooling tube. In one embodiment, at least one cooling tube13 is carried by the elongate body 32 of collar 31 for eachthermoelectric device 12 and extends in the vicinity of suchthermoelectric device 12 for removing heat from the thermoelectricdevice so as to enhance the cooling effect of the thermoelectric devices12. In one embodiment, a cooling tube 13, for example in a serpentineconfiguration, overlies or is disposed adjacent to the heat-generatingsurface 12B of each thermoelectric device 12 for removing heat from suchsurface 12B. In one embodiment, such serpentine configuration is withinthe confines of heat generating surface 12B. The effectiveness ofthermoelectric coolers or devices 12 is enhanced when there is a largetemperature differential between the cold side 12A and the hot side 12Bof the device 7. The inclusion of a high capacity second cooling means,such as a serpentine of cooling tubes 13 carrying cooling fluids forremoving heat from the hot side 12B of the thermoelectric device orapparatus 12, can increase the temperature differential between sides12A and 12B by causing a lower temperature on cold side 12A and thusincrease the effectiveness of devices 12 and collar 31.

Each at least one cooling tube 13 pertaining to a thermoelectric device12, for example each serpentine-configured cooling tube 13, has an inlet13A and an outlet 13B for respectively receiving and discharging coolingfluid flowing through such cooling tube.

In one embodiment, each inlet 13A and outlet 13B may be connected inparallel to corresponding cooling fluid lines 20 and 21, for example asshown in FIG. 7, which are in turn may be connected to a pump unit 14.In this manner, the cooling tubes 13 are not connected in series, andthe cooling fluid from one cooling tube 13 is not utilized by anothercooling tube so as to decrease the efficiency of each cooling tube 13.The parallel configuration of the cooling tubes 13 and the connection ofeach cooling tube to the pump unit facilitates that fluid at the sametemperature is supplied to each thermoelectric device 12. In oneembodiment, each inlet 13A and outlet 13B may be directly connected tothe pump unit, for example as shown in FIG. 8.

In one embodiment, the cooling units 7 of collar may also equipped withtemperature sensors 18, such as of the type discussed above, which inturn may be electrically connected with the control unit 19, which canreceive and analyze the data received from the sensors 18 andautomatically adjust or control the temperature of the cooling fluidsbeing supplied by the pump unit 14 to the cooling tubes. In oneembodiment, a temperature sensor is carried by the elongate body 32 inthe vicinity of each of the cooling means or units 7. In one embodiment,as illustrated in FIG. 8, a temperature sensor 18 is provided in theelongate body 32 adjacent to or within the confines of each coolingmeans 7. One or more temperature sensors for monitoring the temperaturein one or more other areas of the patient's body can be utilized withcollar 31, for example as discussed above with respect to collar 1.

It is appreciated that in the embodiment in which the tube inlets 13Aand tube outlets 13B are connected in parallel with each other, and inthe embodiment in which inlets 13A and outlets 13B are independentlyconnected to the pump unit 14, the temperature changes of the coolingfluids that circulate in the cooling tubes 13 are negligible.

In operation and use, collar 31 can be operated in a manner similar tothe operation of collar 1 discussed above. In this regard, numeral 17 inFIG. 4 schematically designates the center of the brain that controlsthe vital functions of the patient “P.” The temperature of such centeror area 17, located in the occipital region close to the cerebellum 11,can be maintained in a hypothermic state by the collar 1, if required,to avoid brain damage in case of hypoxia or anoxia, irrespective of thecause of these states in the patient “P”. At least some of the coolingelements or devices 7 of the invention, including for example at leastsome of thermoelectric devices 12, can be utilized to cool therespective arteries which such devices overlie to induce hypothermia inthe circulatory system that supplies the brain.

In one embodiment, a therapeutic collar for use by a patient having aneck with a circumference and a first plurality of two carotid arteriesand a second plurality of two vertebral arteries extending through theneck to the brain is provided. The therapeutic collar can include anelongate body adapted for engaging the neck of the patient, the bodybeing made from a flexible material for extending around at least aportion of the neck and having a length approximating the circumferenceof the neck, a first plurality of two thermoelectric devices and asecond plurality of two thermoelectric devices carried by the elongatebody and spaced apart along the length of the elongate body so that thefirst plurality of two thermoelectric devices overlie respectively thefirst plurality of two carotid arteries and the second plurality of twothermoelectric devices overlie respectively the second plurality of twovertebral arteries when the elongate body is secured around the neck ofthe patient, at least one cooling tube carried by the elongate body andextending in the vicinity of each of the thermoelectric devices forremoving heat from the thermoelectric devices so as to enhance thecooling effect of the thermoelectric devices whereby at least some ofthe first and second plurality of two thermoelectric devices can beutilized to cool the respective arteries and thus induce hypothermia inthe circulatory system that supplies the brain.

The elongate body can include an inner portion for engaging the neck,the inner portion including a thermo-conductive layer. Thethermo-conductive layer can be made from a material having a thermalconductivity ranging from 0.2 to 10.0 W/mK. The thermo-conductive layercan be made from a material selected from the group consisting of a softbiocompatible polymer and an adhesive gel. The elongate body can includean outer portion opposite the inner portion, the outer portion includinga thermo-insulating layer. The thermo-insulating layer can be made froma material having a thermal conductivity ranging from 0.01 to 0.19 W/mK.The thermo-insulating layer can be made from a material selected fromthe group consisting of a soft biocompatible polymer, a foam andpolyurethane. The flexible material can be selected from the groupconsisting of polyurethane, silicon and rubber. The therapeutic collarcan include a temperature sensor carried by the elongate body in thevicinity of each thermoelectric device for inhibiting damage to the neckduring cooling. The temperature sensor can be adjacent thethermoelectric device. The at least one cooling tubes extending in thevicinity of each of the thermoelectric devices can extend in parallel.The at least one cooling tubes extending in the vicinity of each of thethermoelectric devices can have respective inlet and outlet ends forcoupling directly to a pump.

In one embodiment, a system for inducing hypothermia in a brain of apatient having a neck with two carotid arteries and two vertebralarteries extending through the neck to the brain is provided. The systemcan include an elongate body adapted for engaging the neck of thepatient, the body being made from a flexible material for extendingaround at least a portion of the neck, a plurality of at least fourthermoelectric devices carried by the elongate body and spaced apartalong the length of the elongate body so that the thermoelectric devicesoverlie respective arteries when the elongate body is secured around atleast a portion of the neck of the patient, a temperature sensor carriedby the elongate body in the vicinity of each thermoelectric device and acontroller electrically coupled to the thermoelectric devices and thetemperature sensors for selectively providing electric energy to thethermoelectric devices so as to cool the respective arteries and thusinduce hypothermia in the circulatory system that supplies the brain andfor obtaining feedback from the temperatures sensors so as to monitortemperatures of the neck in the vicinity of the thermoelectric devicesto inhibit damage to the neck during cooling.

The system can include at least one additional temperature sensorseparate from the elongate body and electrically coupled to thecontroller for monitoring the temperature of another portion of thepatient during cooling. The additional temperature sensor can include atemperature sensor configured to monitor the temperature of the brain,esophagus or bladder of the patient.

In one embodiment, a method for inducing hypothermia in a patient havinga neck with two carotid arteries and two vertebral arteries extendingthrough the neck to the brain is provided. The method can include thesteps of applying electrical energy to a plurality of fourthermoelectric devices each engaging the neck at a position overlyingone of the arteries so as to cool blood passing through the arteries andthus induce hypothermia in the circulatory system that supplies thebrain and monitoring the temperature of the neck nearby thethermoelectric devices with an electrical sensor so as to inhibit damageto the skin nearby the thermoelectric devices during cooling.

The method can include monitoring the temperature of organs within thepatient and adjusting the electrical energy being applied to at leastsome of the plurality of thermoelectric devices in response to themonitored temperatures of the organs. The organs can be selected fromthe group consisting of the stomach, the esophagus and the bladder. Theapplying step can include applying electrical energy to a plurality offour thermoelectric devices each engaging the neck at a positionoverlying one of the arteries so as to cool blood passing through thearteries to a temperature ranging from 89.6 to 96.8 degrees Fahrenheit.The applying step can include applying electrical energy to a pluralityof four thermoelectric devices each engaging the neck at a positionoverlying one of the arteries so as to cool the skin overlying thearteries to a temperature not less than 39.2 degrees Fahrenheit. Theapplying step can include applying electrical energy to a plurality offour thermoelectric devices each engaging the neck at a positionoverlying one of the arteries so as to cool the skin overlying thearteries to a temperature ranging from 41 to 55 degrees Fahrenheit.

In one embodiment, a therapeutic collar designed to be fitted around theneck of a patient is provided. The collar can include an annular bodyhaving a longitudinal axis and comprising two sections that can beparted reciprocally and defining a front section and a rear section andtwo side connecting zones, a dividing plane between said sections; aclosing and opening device of said two sections, a reciprocally coaxialinner wall and an outer wall of said annular body, first refrigeratingmeans fitted in correspondence of said front section, and secondrefrigerating means associated to said inner wall in correspondence ofat least said side and rear sections, characterized in that said firstand second refrigerating means comprise a plurality of refrigerationunits, each refrigeration unit comprising a coupling in a close contactbetween a Peltier cell and a corresponding cooling coil whereinrefrigerating fluids feed by feeding means flow.

The second refrigerating means can include constant refrigerating means.The cooling coils can have respective inlet and outlet ends of saidrefrigerating fluids, which reciprocally are connected in parallel. Thecooling coils can have respective inlet and outlet ends of saidrefrigerating fluids, which reciprocally independently connected with apumping group. The annular body can include heat removal means comingfrom said Peltier cell toward the outside. The second refrigeratingmeans can be associated to said inner wall to contact zones wherein, forexample, carotid arteries and vertebral arteries pass. The collar caninclude an outer thermo-insulating portion and an innerthermo-conductive portion. The dividing plane can be parallel to saidlongitudinal axis. At least a layer of a conductive material can beinterposed between said Peltier cell and cooling coils. The conductivematerial can include a gel containing metallic salts. Each of saidrefrigeration units can include an automatic temperature control sensingmeans.

The invention has been found to fulfill the intended objects.

The invention as conceived is susceptible to changes and variants withinthe inventive concept.

Also, all the details may be replaced by other technical equivalentelements.

In its practical implementation, any material, shape and size may beused as needed, without departure from the scope as defined by thefollowing claims.

The therapeutic collar of the present invention is advantageous in manyrespects. In this regard, for example, the therapeutic collar isdisposable, easily wearable and comfortable for patients. Thetherapeutic collar can maintain the neck of a patient at a desired andsubstantially constant temperature, for a desired and extended intervalof time, without any degradation of thermal treatment. In oneembodiment, the therapeutic collar requires no displacement of thepatient to prepare the required thermal treatment.

I claim:
 1. A method for inducing hypothermia in a patient having a neckwith a carotid artery and a vertebral artery extending through each sideof the neck to anterior cerebral arteries, middle cerebral arteries,posterior cerebral arteries and a basilar artery in a brain, comprisingplacing a collar around the neck, placing a first cooling assemblydirectly over the carotid artery and the vertebral artery on one side ofthe neck and placing a second cooling assembly directly over the carotidartery and the vertebral artery on the other side of the neck, coolingeach of the carotid and vertebral arteries in the neck with the firstcooling assembly and the second cooling assembly, measuring thetemperature of the neck overlying each of the carotid arteries andadjusting the cooling of each of the carotid arteries in response to therespective measured temperature of the carotid arteries and measuringthe temperature of the neck overlying each of the vertebral arteries andadjusting the cooling of each of the vertebral arteries in response tothe respective measured temperature of the vertebral arteries so as tocause controlled cooling of the anterior cerebral arteries, the middlecerebral arteries, the posterior cerebral arteries and the basilarartery and induce hypothermia in the brain of the patient.
 2. The methodof claim 1, further comprising monitoring the temperature of organswithin the patient and adjusting the cooling to at least some of thecarotid arteries and vertebral arteries in response to the monitoredtemperatures of the organs.
 3. The method of claim 2, wherein the organsare selected from the group consisting of a stomach, an esophagus, abladder and a brain.
 4. The method of claim 1, wherein each of the firstcooling assembly and the second cooling assembly includes at least onecooling device carried by the collar and selected from the groupconsisting of a thermoelectric device and a plurality of cooling tubes.5. The method of claim 4, wherein the at least one cooling device is anindependently-controlled cooling device.
 6. The method of claim 1,wherein the placing the collar step includes securing the collar aroundthe neck of the patient.
 7. A method for inducing hypothermia in apatient having a neck with a carotid artery and a vertebral arteryextending through each side of the neck to anterior cerebral arteries,middle cerebral arteries, posterior cerebral arteries and a basilarartery in a brain, comprising placing a first independently-controlledcooling assembly directly over the carotid artery and the vertebralartery on one side of the neck and placing a secondindependently-controlled cooling assembly directly over the carotidartery and the vertebral artery on the other side of the neck, coolingeach of the carotid and vertebral arteries in the neck with the firstindependently-controlled cooling assembly and the secondindependently-controlled cooling assembly, measuring the temperature ofthe neck overlying each of the carotid arteries and adjusting thecooling of each of the carotid arteries in response to the respectivemeasured temperature of the carotid arteries and measuring thetemperature of the neck overlying each of the vertebral arteries andadjusting the cooling of each of the vertebral arteries in response tothe respective measured temperature of the vertebral arteries so as tocause controlled cooling of the anterior cerebral arteries, the middlecerebral arteries, the posterior cerebral arteries and the basilarartery and induce hypothermia in the brain of the patient.
 8. The methodof claim 7, wherein each of the first independently-controlled coolingassembly and the second independently-controlled cooling assemblyincludes at least one cooling device selected from the group consistingof a thermoelectric device and a plurality of cooling tubes.
 9. Themethod of claim 7, wherein each independently-controlled coolingassembly includes a thermoelectric device.
 10. The method of claim 7,wherein all of the independently-controlled cooling assemblies arecarried by a collar that can be secured around the neck of the patient.11. A method for inducing hypothermia in a patient having a neck with acarotid artery and a vertebral artery extending through each side of theneck to anterior cerebral arteries, middle cerebral arteries, posteriorcerebral arteries and a basilar artery in a brain, comprising placing afirst independently-controlled cooling assembly directly over thecarotid artery and the vertebral artery on one side of the neck andplacing a second independently-controlled cooling assembly directly overthe carotid artery and the vertebral artery on the other side of theneck and cooling each of the carotid and vertebral arteries in the neckwith the first independently-controlled cooling assembly and the secondindependently-controlled cooling assembly, measuring the temperature ofthe neck overlying each of the carotid arteries and adjusting thecooling of at least one of the carotid arteries in response to themeasured temperature of the at least one of the carotid arteries andmeasuring the temperature of the neck overlying each of the vertebralarteries and adjusting the cooling of at least one of the vertebralarteries in response to the measured temperature of the at least one ofthe vertebral arteries so as to cause controlled cooling of the anteriorcerebral arteries, the middle cerebral arteries, the posterior cerebralarteries and the basilar artery and induce hypothermia in the brain ofthe patient.
 12. The method of claim 11, wherein each of the firstindependently-controlled cooling assembly and the secondindependently-controlled cooling assembly includes at least one coolingdevice selected from the group consisting of a thermoelectric device anda plurality of cooling tubes.
 13. The method of claim 11, wherein all ofthe independently-controlled cooling assemblies are carried by a collarthat can be secured around the neck of the patient.